Low-dose long-term oral idarubicin in maintenance treatment of elderly acute myeloid leukemia
Musso, M.; Porretto, F.; Crescimanno, A.; Bondì, F.; Polizzi, V.; Scalone, R.; Tolomeo, M.; Mariani, G.
Haematologica 82(5 Suppl): 4-8
1997
ISSN/ISBN: 0390-6078 PMID: 9402746 Document Number: 479458
Background and Objective. Low-dose long-term oral IDA may play a role in maintenance treatment of elderly patients with AML; in fact, continuous exposure to IDA and IDAol could be efficacious in the disease control possibly inducing cell differentiation and/or apoptosis. Methods. We enrolled 25 previous responder patients in standard induction therapy to receive maintenance oral IDA 5 mg daily on days 1-14 at 2-week intervals for at least 6 months. We also evaluated the cell-cycle and apoptosis in leukemic cells from patients after IDA administration and, as a control, from HL60 lines exposed to IDA and IDAol in vitro. Results. Long-term long-dose IDA was well-tolerated. Neutrophil and platelet count never below under 1 X 109/L and 50 X 109/L respectively in CR patients, and no infectious complications were encountered. Non-hematological toxicity was also acceptable: easily controlled nausea and vomiting, non-recorded diarrhea or mucositis were reported. The convenience of oral administration contributed to excellent compliance. DNA analysis performed in vivo after IDA and IDAol exposure showed an increase of G2/M cell frequencies and evidence of sub-G1 peak. Interpretation and Conclusions. In conclusion, long-term low doses of oral IDA would appear valuable as a maintenance regimen for elderly patients. Our results seem to confirm the preliminary hypothesis that IDA + IDAol induce an increase of apoptosis in leukemic cells.